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510(k) K963136

PACER MODEL 100 INFUSION CONTROLLER by Health Watch, Inc. — Product Code LDR

K963136 is an FDA 510(k) premarket notification submitted by Health Watch, Inc. for the device "PACER MODEL 100 INFUSION CONTROLLER". The FDA issued a decision of Substantially Equivalent on October 10, 1997. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Health Watch, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1997
Date Received
August 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Health Watch, Inc.

  • K921331 — CAMBRIDGE PC/GXT STRESS TEST SYSTEM (May 11, 1992)

Other clearances for product code LDR

  • K242693 — DEKA Infusion System, DEKA Administration Set (October 7, 2024)
  • K232316 — DEKA Infusion System, DEKA Administration Set (March 1, 2024)
  • K153760 — Volumetric Infusion Controller (October 3, 2016)
  • K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (July 3, 1997)
  • K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (July 3, 1997)
  • K934543 — UNIVERSAL CONTROLLER, MODEL 100 (March 29, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)
  • K896907 — 3M IV FLOW REGULATOR (February 26, 1990)

FDA data resources